EP3674310B1 - Immunoglobulin purification using pre-cleaning steps - Google Patents

Immunoglobulin purification using pre-cleaning steps

Info

Publication number: EP3674310B1
Authority: EP; European Patent Office
Prior art keywords: immunoglobulin; protein; chromatography; resin; exchange chromatography
Prior art date: 2014-03-10
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.): Active

Application number

EP20155836.8A

Other languages

German (de)

English (en)

French (fr)

Other versions

EP3674310A1 (en

Inventor

Ferenc FELFÖLDI

Zsuzsa BENKÖ

Melinda GÁSPÁR

Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)

Richter Gedeon Nyrt

Original Assignee

Richter Gedeon Nyrt

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

2014-03-10

Filing date

2015-03-09

Publication date

2026-05-06

2014-03-10 Priority claimed from HU1400131A external-priority patent/HUP1400131A1/hu

2015-02-09 Priority claimed from HU1500053A external-priority patent/HUP1500053A1/hu

2015-03-09 Application filed by Richter Gedeon Nyrt filed Critical Richter Gedeon Nyrt

2020-07-01 Publication of EP3674310A1 publication Critical patent/EP3674310A1/en

2026-05-06 Application granted granted Critical

2026-05-06 Publication of EP3674310B1 publication Critical patent/EP3674310B1/en

Status Active legal-status Critical Current

2035-03-09 Anticipated expiration legal-status Critical

Links

Classifications

- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J39/00—Cation exchange; Use of material as cation exchangers; Treatment of material for improving the cation exchange properties
- B01J39/26—Cation exchangers for chromatographic processes
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J41/00—Anion exchange; Use of material as anion exchangers; Treatment of material for improving the anion exchange properties
- B01J41/20—Anion exchangers for chromatographic processes
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/165—Extraction; Separation; Purification by chromatography mixed-mode chromatography
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/18—Ion-exchange chromatography
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
- C07K16/065—Purification, fragmentation
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/241—Tumor Necrosis Factors
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2887—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20

Landscapes

Chemical & Material Sciences (AREA)
Organic Chemistry (AREA)
Health & Medical Sciences (AREA)
General Health & Medical Sciences (AREA)
Medicinal Chemistry (AREA)
Life Sciences & Earth Sciences (AREA)
Biochemistry (AREA)
Biophysics (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Genetics & Genomics (AREA)
Molecular Biology (AREA)
Analytical Chemistry (AREA)
Immunology (AREA)
Chemical Kinetics & Catalysis (AREA)
Engineering & Computer Science (AREA)
Water Supply & Treatment (AREA)
Peptides Or Proteins (AREA)
Treatment Of Liquids With Adsorbents In General (AREA)
Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

EP20155836.8A 2014-03-10 2015-03-09 Immunoglobulin purification using pre-cleaning steps Active EP3674310B1 (en)

Applications Claiming Priority (4)

Application Number	Priority Date	Filing Date	Title
HU1400131A HUP1400131A1 (hu)	2014-03-10	2014-03-10	Immunoglobulin tisztítása elõtisztítási lépések alkalmazásával
HU1500053A HUP1500053A1 (hu)	2015-02-09	2015-02-09	Immunglobulin tisztítása elõtisztítási lépések alkalmazásával
EP15708522.6A EP3116891B1 (en)	2014-03-10	2015-03-09	Immunoglobulin purification using pre-cleaning steps
PCT/EP2015/054862 WO2015135884A1 (en)	2014-03-10	2015-03-09	Immunoglobulin purification using pre-cleaning steps

Related Parent Applications (1)

Application Number	Title	Priority Date	Filing Date
EP15708522.6A Division EP3116891B1 (en)	2014-03-10	2015-03-09	Immunoglobulin purification using pre-cleaning steps

Publications (2)

Publication Number	Publication Date
EP3674310A1 EP3674310A1 (en)	2020-07-01
EP3674310B1 true EP3674310B1 (en)	2026-05-06

Family

ID=89991731

Family Applications (2)

Application Number	Title	Priority Date	Filing Date
EP15708522.6A Active EP3116891B1 (en)	2014-03-10	2015-03-09	Immunoglobulin purification using pre-cleaning steps
EP20155836.8A Active EP3674310B1 (en)	2014-03-10	2015-03-09	Immunoglobulin purification using pre-cleaning steps

Family Applications Before (1)

Application Number	Title	Priority Date	Filing Date
EP15708522.6A Active EP3116891B1 (en)	2014-03-10	2015-03-09	Immunoglobulin purification using pre-cleaning steps

Country Status (15)

Country	Link
US (1)	US10487138B2 (pl)
EP (2)	EP3116891B1 (pl)
JP (1)	JP6293907B2 (pl)
KR (1)	KR101921552B1 (pl)
CN (1)	CN106103465B (pl)
CA (1)	CA2930350C (pl)
DK (1)	DK3116891T3 (pl)
ES (1)	ES2784749T3 (pl)
HR (1)	HRP20200711T1 (pl)
HU (1)	HUE048782T2 (pl)
LT (1)	LT3116891T (pl)
PL (1)	PL3116891T3 (pl)
PT (1)	PT3116891T (pl)
SI (1)	SI3116891T1 (pl)
WO (1)	WO2015135884A1 (pl)

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SI3116891T1 (sl)	2014-03-10	2020-07-31	Richter Gedeon Nyrt.	Čiščenje imunoglobulina z uporabo predčistilnih stopenj
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JP6851109B2 (ja) *	2016-06-16	2021-03-31	Jsr株式会社	抗体を精製する方法及び担体を洗浄する方法
TWI798179B (zh) *	2016-06-17	2023-04-11	美商建南德克公司	多特異性抗體之純化
EP3512884A4 (en) *	2016-09-14	2020-09-16	Kinbio Ltd.	METHODS FOR CLEANING UP AND QUALIFYING ANTIBODIES
MX2019011343A (es) *	2017-03-24	2019-11-18	Council Scient Ind Res	Un procedimiento para la purificacion de fragmentos de anticuerpos recombinantes.
MA49962A (fr) *	2017-08-22	2020-07-01	Biogen Ma Inc	Procédés de purification d'anticorps présentant des agrégats réduits à poids moléculaire élevé
KR20190047376A (ko)	2017-10-27	2019-05-08	주식회사 녹십자	개선된 면역글로불린의 정제방법
CN111818980B (zh) *	2018-03-08	2022-10-11	生物辐射实验室股份有限公司	阴离子交换-疏水混合模式色谱树脂
WO2019183334A1 (en)	2018-03-21	2019-09-26	Waters Technologies Corporation	Non-antibody high-affinity-based sample preparation, sorbents, devices and methods
GB201805142D0 (en) *	2018-03-29	2018-05-16	Ge Healthcare Bioprocess R&D Ab	Separation method
EP3823594B1 (en) *	2018-07-19	2025-02-05	Ichnos Sciences S.A.	Liquid antibody formulation
KR102262012B1 (ko)	2018-10-15	2021-06-09	연세대학교 산학협력단	생산성이 향상된 항체 및 이의 제조방법
KR102209790B1 (ko) *	2018-12-20	2021-02-01	에이치케이이노엔 주식회사	친화성 크로마토그래피를 이용한 백신용 바이러스 정제방법
CN119716045A (zh)	2018-12-30	2025-03-28	豪夫迈·罗氏有限公司	基于pH梯度SPR的结合测定
SG11202107870RA (en) *	2019-03-21	2021-08-30	Agency Science Tech & Res	A method of capturing and/or purifying a target
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HU231498B1 (hu)	2019-04-04	2024-05-28	Richter Gedeon Nyrt	Immunglobulinok affinitás kromatográfiájának fejlesztése kötést megelőző flokkulálás alkalmazásával
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US11896969B2 (en)	2019-09-05	2024-02-13	Bio-Rad Laboratories, Inc.	Anionic exchange-hydrophobic mixed mode chromatography resins
US11732004B2 (en)	2020-04-10	2023-08-22	Plasma Technologies, Llc	Compositions and methods for simplified high efficiency isolation of proteins
CN113563469A (zh) *	2020-04-28	2021-10-29	江苏中新医药有限公司	高回收率纯化阿达木单抗的方法
EP4142905A4 (en) *	2020-05-01	2024-11-13	Kashiv Biosciences, LLC	IMPROVED PROCESS FOR PURIFICATION OF PROTEIN
AU2021262609A1 (en)	2020-05-01	2022-12-22	Kashiv Biosciences, Llc	An improved process of purification of protein
ES3040791T3 (en) *	2020-12-18	2025-11-05	Richter Gedeon Nyrt	Methods for the purification of refolded fc-peptide fusion protein
AU2022361768A1 (en) *	2021-10-08	2024-05-02	Kashiv Biosciences, Llc	Separation of pre-peak and post-peak in fusion protein sample by using size exclusion high performance liquid chromatography
WO2023057994A1 (en) *	2021-10-08	2023-04-13	Kashiv Biosciences, Llc	Separation of pre-peak in fusion protein sample by using size exclusion high performance liquid chromatography
CN114133446A (zh) *	2021-12-31	2022-03-04	方坦思(上海)生物医药有限公司	单克隆抗体的纯化方法
CN115304673B (zh) *	2022-06-24	2024-10-01	上海赛伦生物技术股份有限公司	一种马抗破伤风特异性免疫球蛋白F(ab’)2的纯化方法及其应用

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2015
- 2015-03-09 SI SI201531188T patent/SI3116891T1/sl unknown
- 2015-03-09 KR KR1020167022454A patent/KR101921552B1/ko active Active
- 2015-03-09 EP EP15708522.6A patent/EP3116891B1/en active Active
- 2015-03-09 HU HUE15708522A patent/HUE048782T2/hu unknown
- 2015-03-09 CA CA2930350A patent/CA2930350C/en active Active
- 2015-03-09 ES ES15708522T patent/ES2784749T3/es active Active
- 2015-03-09 LT LTEP15708522.6T patent/LT3116891T/lt unknown
- 2015-03-09 PT PT157085226T patent/PT3116891T/pt unknown
- 2015-03-09 PL PL15708522T patent/PL3116891T3/pl unknown
- 2015-03-09 HR HRP20200711TT patent/HRP20200711T1/hr unknown
- 2015-03-09 DK DK15708522.6T patent/DK3116891T3/da active
- 2015-03-09 EP EP20155836.8A patent/EP3674310B1/en active Active
- 2015-03-09 WO PCT/EP2015/054862 patent/WO2015135884A1/en not_active Ceased
- 2015-03-09 US US15/120,359 patent/US10487138B2/en active Active
- 2015-03-09 JP JP2016544089A patent/JP6293907B2/ja active Active
- 2015-03-09 CN CN201580012972.5A patent/CN106103465B/zh active Active

Patent Citations (1)

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Publication number	Priority date	Publication date	Assignee	Title
WO2013189544A1 (en) *	2012-06-21	2013-12-27	Synthon B.V.	Method of purifying an antibody

Also Published As

Publication number	Publication date
CN106103465A (zh)	2016-11-09
JP6293907B2 (ja)	2018-03-14
CN106103465B (zh)	2021-01-08
DK3116891T3 (da)	2020-05-04
ES2784749T3 (es)	2020-09-30
HUE048782T2 (hu)	2020-08-28
SI3116891T1 (sl)	2020-07-31
HRP20200711T1 (hr)	2020-07-24
CA2930350A1 (en)	2015-09-17
KR101921552B1 (ko)	2018-11-23
WO2015135884A1 (en)	2015-09-17
JP2017507907A (ja)	2017-03-23
EP3674310A1 (en)	2020-07-01
US20170058019A1 (en)	2017-03-02
PL3116891T3 (pl)	2020-07-27
US10487138B2 (en)	2019-11-26
LT3116891T (lt)	2020-03-25
KR20160124107A (ko)	2016-10-26
CA2930350C (en)	2021-04-06
EP3116891B1 (en)	2020-02-12
PT3116891T (pt)	2020-05-18
EP3116891A1 (en)	2017-01-18

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